Belli Acne Control Spot Treatment Cream
FDA Label NDC 42281-001
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Body Halo Llc for the product Belli Acne Control Spot Treatment (NDC 42281-001). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding belli acne control spot treatment, active ingredient, purpose, uses, warnings, when using this product, stop use and ask a doctor if, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Colloidal Sulfur 3%
Purpose
Anti-Acne Agent
Uses
- reduces the severity of acne blemishes
- helps prevent new acne blemishes
Warnings
For external use only. Using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor. Do not get into eyes. If excessive skin irritation develops or increases, discontinue use and consult a doctor.
When Using This Product
- keep out of eyes
- rinse with water to remove
Stop Use And Ask A Doctor If
- rash or skin irritation develops
Keep Out Of Reach Of Children
In case of accidental ingestion, contact a Poison Control Center immediately.
Directions
- cleanse the skin thoroughly before applying medication
- cover the entire affected area with a thin layer one to three times daily
- because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a physician
- if bothersome dryness or peeling occurs, reduce application to once a day or every other day
Other Information
- store below 77 degrees F / 25 degrees C
Inactive Ingredients
Caprylyl Glycol, Chamomilla Recutita (Matricaria) Flower Extract, Cucumis Sativus (Cucumber) Fruit Extract, Deionized Water, Ethylhexylglycerin, Leuconostoc/Radish Root Ferment Filtrate, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Potassium Sorbate, Sodium PCA, Xanthan Gum
Belli Acne Control Spot Treatment 14.75Ml (42281-001-00)
* Please review the disclaimer below.